Senior Director, Pharmacovigilance (PV) Operations
General Scope and Summary
Sage Therapeutics is searching for an experienced Senior Director, Pharmacovigilance (PV) Operations that is a creative, resourceful, and integrative thinker. This position is responsible for creating, directing, and managing the company’s infrastructure and staff to support the operational aspects of the pharmacovigilance system to adhere to all global regulatory requirements and internal processes and procedures. The qualified candidate will have experience in and perform multiple activities related to overall safety operations strategy across the portfolio, including SAGE case management, database strategy, vendor oversight, compliance, inspection readiness, contracts, and training. In addition, this position must build and maintain relationships with key strategic internal and external stakeholders, including the hiring and training of Drug Safety and Pharmacovigilance personnel.
Roles and Responsibilities
Provide strategic planning, implementation, and management of DSPV Operations activities.
Manage internal and external staff allocated to operational DSPV activities, creating a highly efficient team across insourced and outsourced resources.
Provide expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH, US and international regulations and guidelines, and Good Pharmacovigilance Practice (GPvP).
Build and implement pharmacovigilance systems that are fully compliant with the applicable worldwide Health Authority PV regulations.
Ensure that the DSPV database supports the department needs, including specific workflows and reporting/querying functionalities. Provide oversight of systems and MedDRA updates in collaboration with the relevant DSPV vendor.
Contribute to the selection of DSPV vendors to support an outsourced DSPV business model. Provide vendor oversight and management for all outsourced or insourced PV activities, including establishing and monitoring key quality and compliance metrics.
Develop and implement an inspection readiness program with the contribution of other DSPV and non-PV stakeholders.
Responsible for a compliant and quality execution of all operational activities related to case management and related activities. Oversee timely submissions of expedited reports to the FDA and other health authorities. Immediately identify deviations and applicable corrective and preventive actions to maintain the compliance to reporting at its highest level.
Establish a system for prevention and correction of deviations to compliance with internal and external stakeholders, in collaboration with the Sage Quality group.
Oversee the setup of new safety projects, including development of study-specific Safety Management Plans and setup of safety systems and database configurations in the PV database to accommodate these trials and products.
Contribute to, draft, and implement department SOPs and work instructions related to the DSPV activities.
Contribute to the signal detection, benefit-risk profile assessment, and aggregate reporting activities with providing accurate reports from the DSPV database.
Effectively collaborate with key stakeholders at all levels in the organization, including Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs, and Manufacturing to develop compliant procedures in line with industry standards and best practices.
Represent DSPV as a leader on project teams, other departments, and committees as needed.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful, and efficient. Must have excellent interpersonal skills, the ability to develop important relationships with key stakeholders, and the ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations. Must have a demonstrated ability to translate strategy into action, excellent analytical skills, and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Bachelor’s degree in life sciences, pharmacy, nursing, or equivalent health experience; advanced life sciences degree or MBA preferred.
8+ years of experience in a drug safety/pharmacovigilance role in the pharmaceutical industry; 6+ years of experience in a managerial role in drug safety.
A natural leader with effective organizational, interpersonal, communication, and managerial skills who is able to motivate and inspire others.
Demonstrated ability to create, evaluate, and maintain effective business processes and implement procedures, systems, and tools to maximize resources within a Drug Safety department.
Thorough knowledge and experience in all aspects of safety reporting for clinical trials and marketed situations.
Strong knowledge and experience with currently available drug safety database systems, document management systems, and QC tools. This also includes MedDRA and linked technologies.
Operational expertise with ARGUS preferred.
Level will be commensurate upon experience and qualifications.
Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
Strong team player that has a customer service approach and is solution-oriented.
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
Possesses strong written and verbal communication skills.
Embrace our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.
Excitement about the vision and mission of Sage.
All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.
All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.